University of Alabama at Birmingham's Experience
The Centers for Disease Control and Prevention (CDC) Vision Health Initiative funded three centers in 2019 to develop and evaluate intervention strategies for enhancing early detection and management of glaucoma and other eye diseases in underserved, at-risk populations. The trials, entitled Screening and Interventions for Glaucoma and Eye Health through Telemedicine (SIGHT https://sightstudies.org/), are ongoing at the University of Michigan (MI-SIGHT),5 Columbia University (NYC-SIGHT),6 and the University of Alabama at Birmingham (UAB) (AL-SIGHT).7 AL-SIGHT’s purpose is to provide ocular screening for glaucoma, glaucoma-associated diseases (GAD) such as glaucoma suspect and ocular hypertension, diabetic retinopathy (DR), cataract, refractive error, and other eye conditions among underserved communities in rural Alabama who are patients at federally qualified health centers (FQHCs). We used both advanced structural imaging devices and visual functional evaluation, with the data being electronically transmitted to a remote ophthalmologist for diagnostic reading.
AL-SIGHT was designed and implemented by a team of clinician-scientists, including ophthalmologists with fellowship training in glaucoma, optometrists, vision science researchers, family medicine physicians, statisticians, and clinical research coordinators (2 FTEs) in the Department of Ophthalmology and Visual Sciences and the Department of Family and
Community Medicine at UAB. The study sites are 3 FQHCs that are part of the Cahaba Medical Care Foundation, an Alabama-based FQHC. With a total of 9 FQHC clinics located in both urban and rural counties of Alabama, Cahaba’s rural clinics serve an area with the highest poverty rate in the US. Cahaba has over 16,000 active patients per year seen in its clinics, including 58% African American, 38% White, and <3% Hispanic patients. Cahaba serves a large proportion of Medicaid (25% of patients) and uninsured (20%) populations, in addition to patients who have Medicare (30%) and private insurance (25%). The clinic locations for the study are Centreville (Bibb County, AL), Maplesville (Chilton County, AL), and Marion (Perry County, AL). We selected a geographic region with a population of socioeconomically disadvantaged individuals having significant barriers to receiving subspecialty ophthalmology care who are also at the greatest risk from glaucoma and DR.
University of Alabama at Birmingham:
Screening Program
Goal – The primary goal is to improve the accessibility of glaucoma and other eye disease detection and management among an at-risk population using a telemedicine model. We also want to evaluate methods to improve patient adherence to follow-up appointments, such as an evidence-based glaucoma education program and comparison of a financial incentive ($50 debit card) to patients if they attended a follow-up examination versus no financial incentive.
Equipment – Autorefraction is carried out with the QuickSee (PlenOptika Inc, USA) or Retinomax (Nikon, Tokyo, Japan). Intraocular pressure (IOP) is measured with the iCare portable rebound tonometer (iCare USA, Raleigh, NC). A combined spectral domain optical coherence tomography (SD-OCT) and fundus camera device (Maestro2, Topcon Medical Systems, New Jersey, USA) images the fundus. Functional assessment of the optic nerve is achieved through perimetry testing using three different types of testing: a traditional Humphrey Field Analyzer screening strategy SITA-FAST (Carl Zeiss Meditec, California, USA), a tablet-based perimetry application (Melbourne Rapid Fields application, M&S Technologies, Illinois, USA), and a virtual reality-based perimeter (VisuALL, Olleyes, New Jersey, USA).
Screening Exam – One of two clinical research coordinators is at each of the three FQHC sites, 1-2 days per week. The coordinator performs all the testing and data transfer in a clinic exam room. The equipment is stored out of the way of the primary care clinic’s needs when not in use. While the complete protocol takes about an hour, much of this protocol is designed to meet specific research goals and may not apply in other settings. Before the ocular screening, an interviewer-administered questionnaire is obtained for demographic data (birthdate, gender, race, and ethnicity), marital status, medical insurance status, transportation availability, education attainment level, employment status, reasons for no eye exam in more than two years, and contact information. For clinical characteristics, information is also collected on smoking status, family history of glaucoma or blindness, and ocular history. Family history of glaucoma is considered positive if a participant reported a glaucoma diagnosis for a first-degree relative (parent, sibling, or child).
Telemedicine ocular screening is implemented as follows by a clinical research coordinator with a background as an ophthalmic technician. Distance visual acuity is assessed using a Snellen chart presented at 20 feet while the participant wears whatever correction (if any) they have. Autorefraction and IOP are measured. A second IOP measurement is taken if the IOP is> 21 mmHg. If these 2 IOPs differ by more than 2 mmHg, a third measurement is taken. If IOP is measured twice, the mean value is used as the IOP; if it is measured three times, the middle value is used. Participants with IOP ≥ 30mmHg are referred to an optometrist or ophthalmologist in our fast-track protocol: IOP > 30mmHg within two weeks; IOP > 35 mmHg, within 1 week; and IOP > 40 mmHg, an urgent referral within one day.
Structural and functional assessment of the optic nerve and fundus occurs through undilated pupils. The retinal nerve fiber layer thickness of the optic nerve head and the macular thickness are measured with the Maestro2. Functional assessment of the optic nerve is achieved through perimetry testing using three different types of testing. After the ocular testing, a satisfaction survey is administered to the participant.
How Patients Enter the Screening – Patients presenting at the FQHCs are eligible to participate if they have one or more risk factors for GAD and volunteer to participate: (1) people who identify as African American or Hispanic people ≥40 years; (2) White people ≥50 years; (3) anyone ≥18 years with diabetes, (4) anyone ≥18 years with a GAD; (5) anyone ≥18 years with a family history of glaucoma. All participants have spoken and understood English. Study participants are recruited through several methods.8 The electronic medical record of Cahaba is searched monthly by Cahaba staff using the study eligibility criteria, and potential participants are mailed recruitment letters. The clinical research coordinators then call the participants two weeks after letters were mailed to follow up on the invitation to participate. Also, the primary care clinicians and clinic staff at the FQHC sites refer patients meeting the eligibility criteria directly to the clinical research coordinator. All participants receive compensation for study enrollment in the form of a UAB ClinCard, a secure, pre-loaded participant payment card used as a debit or credit card.
Interpreting the Exam – The ocular screening data is read remotely by an ophthalmologist with fellowship training in glaucoma at UAB who makes diagnostic judgments per eye about glaucoma, glaucoma suspect, ocular hypertension, DR, cataract, refractive error, and other ocular conditions. Diagnoses are based on review of retinal imaging and visual function, medical history, ocular history, and demographic characteristics. Diagnoses of DR are based on the National Health Service Grading Classification System.3
How the results are communicated to the patient and clinician – Each participant, the FQHC primary care clinician, and their eye care clinician (if they had one) receive the final report from the remote assessment. These are faxed to the PCP within 14 days of the participant’s screening visit date and mailed to the patient’s house. The report contains diagnostic information on the conditions named above, plus visual acuity, IOP, recommended treatment, and follow-up.
Billing – This screening program is entirely funded through a federal grant from the CDC. This includes salary support, equipment, participant financial incentives, and a fee for service to the FQHC. There is no billing of participant insurance through the FQHC.
Scheduling Follow-up Care – Participants who are clinically judged as normal by the ophthalmologist are recommended to undergo an annual comprehensive eye examination. The following participants are recommended for a follow-up examination visit with an optometrist who is partnered with the FQHC (located in a separate office), or an ophthalmologist at the Glaucoma Service at UAB, the Lions Eye Clinic at UAB, or an ophthalmologist whose clinic is located in the FQHC geographic area: those with 20/40 or worse visual acuity or had IOP ≥ 23 mmHg in either eye; those with GAD (glaucoma, glaucoma suspect, or ocular hypertension), DR, or other ocular condition that the ophthalmologist viewed as needing to be examined in person. The FQHC staff schedules the appointment and communicates the details to the participant. The clinical research coordinator follows up with the clinic where each participant was scheduled to determine if they actually attended the appointment.
Measuring Screening Outcomes – As a federally funded research clinical trial, the outcomes of this program will be rigorously analyzed in an effort to provide useful guidance for future programs. The evaluation of the performance of the individual structural and functional imaging devices in remote eye disease detection will be assessed using statistical analyses that compare the effectiveness of the devices’ diagnoses against a standard diagnosis. For example, is the SD-OCT necessary? Is perimetry necessary, and if so, which device performs the best in a community-based program? We will evaluate strategies to overcome the barriers to patient adherence with referral and follow-up appointments by comparing the effectiveness of financial incentives along with a validated patient education program versus a validated patient education program alone. A cost analysis and cost-effectiveness analysis will be conducted based on the outcomes. We expect that our study results will be able to inform: (1) whether a telemedicine system in rural FQHCs performed on at-risk patients will detect glaucoma at an equivalent rate as traditional in-person examination by a glaucoma specialist; (2) whether an eye health education program improves adherence to follow-up appointments with or without the addition of financial incentives; (3) whether education improves knowledge, attitudes, and beliefs about glaucoma, its management, and the importance of routine comprehensive eye care.